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A Prospective Randomized Study for Comparison of Y-Composite Grafts (SAVERITA)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

saphenous vein composite grafting

right internal thoracic artery composite grafting

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age equal or more than 40
age equal or less than 75
patients who agree to the enrollment

Exclusion Criteria:

Patients with heart failure (left ventricular ejection fraction < 25%)
patients who have intractable ventricular arrhythmia
patients who has been treated for cancer
patients who has infectious disease
patients who are planned to undergo combined cardiac surgery
patients who has medical co-morbidity with expected survival less than 1 year
patients who has a problem using right internal thoracic artery or saphenous vein
patients with a history of previous cardiac surgery
Patients with chronic renal failure
patients who undergo emergency operation

Sites / Locations

Seoul National Uinversity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

SVG group

RITA group

Arm Description

patients who underwent off-pump coronary artery bypass using saphenous vein composite grafting based on the left internal thoracic artery use saphenous vein as a composite graft connected to the left internal thoracic artery

patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite grafting based on the left internal thoracic artery use right internal thoracic artery as a composite graft connected to the left internal thoracic artery

Outcomes

Primary Outcome Measures

1 Year Graft Patency Rates

1 year graft patency of second limb conduits measured by 1 year coronary angiography

Secondary Outcome Measures

Overall Survival

Overall survival rate at 4 years

Freedom From Cardiac Death

Freedom rate from cardiac death at 4 years

Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

Early Angiographic Patency Rates

The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG

Full Information

NCT ID

NCT01051986

First Posted

January 17, 2010

Last Updated

November 21, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01051986

Brief Title

A Prospective Randomized Study for Comparison of Y-Composite Grafts

Acronym

SAVERITA

Official Title

A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

Detailed Description

The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SVG group

Arm Type

Active Comparator

Arm Description

Arm Title

RITA group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

saphenous vein composite grafting

Other Intervention Name(s)

SAVERITA SVG

Intervention Description

use saphenous vein as a composite graft connected to the left internal thoracic artery

Intervention Type

Procedure

Intervention Name(s)

right internal thoracic artery composite grafting

Other Intervention Name(s)

SAVERITA RITA

Intervention Description

right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery

Primary Outcome Measure Information:

Title

1 Year Graft Patency Rates

Description

1 year graft patency of second limb conduits measured by 1 year coronary angiography

Time Frame

one year

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival rate at 4 years

Time Frame

4 years

Title

Freedom From Cardiac Death

Description

Freedom rate from cardiac death at 4 years

Time Frame

4 years

Title

Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

Description

freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

Time Frame

4 years

Title

Early Angiographic Patency Rates

Description

The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG

Time Frame

1.4days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age equal or more than 40 age equal or less than 75 patients who agree to the enrollment Exclusion Criteria: Patients with heart failure (left ventricular ejection fraction < 25%) patients who have intractable ventricular arrhythmia patients who has been treated for cancer patients who has infectious disease patients who are planned to undergo combined cardiac surgery patients who has medical co-morbidity with expected survival less than 1 year patients who has a problem using right internal thoracic artery or saphenous vein patients with a history of previous cardiac surgery Patients with chronic renal failure patients who undergo emergency operation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ki-Bong Kim, MD, PhD

Organizational Affiliation

Department of throacic and cardiovascular surgery, Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National Uinversity Hospital

City

Seoul

ZIP/Postal Code

110 744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24973924

Citation

Kim KB, Hwang HY, Hahn S, Kim JS, Oh SJ. A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes. J Thorac Cardiovasc Surg. 2014 Sep;148(3):901-7; discussion 907-8. doi: 10.1016/j.jtcvs.2014.03.057. Epub 2014 May 16.

Results Reference

derived

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A Prospective Randomized Study for Comparison of Y-Composite Grafts

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